[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gastroesophageal-cancer-gc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gastroesophageal-cancer-gc":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,68,92,123,160],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":39,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":67},"100614270","phase-1-a-study-of-ide892-as-monotherapy-and-combination-in-mtap-deleted-advanced-solid-tumors-100614270",false,"NCT07277413","A Study of IDE892 as Monotherapy and Combination in MTAP-deleted Advanced Solid Tumors","A Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE892 as Monotherapy and Combination Therapy in Participants With MTAP-Deleted Advanced Solid Tumors","Inclusion Criteria:\n\n* Are ≥ 18 years of age (or the minimum age of consent in accordance with local regulations) at the time of signing the ICF.\n* Have a histologically confirmed diagnosis of a locally advanced recurrent or metastatic solid tumor type of interest with MTAP deletion (for dose escalation: mesothelioma \\[pleural or peritoneal\\], gastroesophageal cancers \\[squamous and adenocarcinoma of esophagus, gastric adenocarcinoma, gastroesophageal junction cancers\\], pancreatic adenocarcinoma and biliary tract carcinomas (intrahepatic and extrahepatic cholangiocarcinoma, and gallbladder cancer), NSCLC \\[adenocarcinoma, squamous cell carcinoma, and adeno-squamous\\] or UC \\[including mixed urothelial-squamous histology\\]; for dose expansion: NSCLC that has progressed on at least one prior line of treatment and for which additional effective standard therapy is not available or for which the participant is not a candidate due to intolerance).\n* Are willing and able to provide blood\u002Ftumor tissue samples for biomarker testing. An archival tumor tissue specimen must be provided for central confirmation of MTAP loss.\n* Must be willing and able to provide the blood\u002Fserum\u002Fplasma samples\n* Have evidence of homozygous loss of MTAP or MTAP deletion (pre-screening available after signing pre-screening ICF)\n* Have at least 1 measurable lesion according to RECIST version 1.1\n* Have Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1\n* Have life expectancy \\> 3 months\n* Have adequate bone marrow and organ function\n* Able to swallow and retain orally administered study drug\u002FIMP.\n* Are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures\n* Male and female: willing to use contraception\n\nExclusion Criteria:\n\n* Known symptomatic brain metastases requiring supraphysiologic doses of systemic corticosteroids\n* Have a known primary central nervous system (CNS) malignancy\n* Have had other malignancies within 2 years prior to the first dose, with some exceptions\n* Impaired cardiac function or clinically significant cardiac diseases\n* Have presence of uncontrolled pleural, peritoneal, or pericardial effusion within 2 weeks before the first study dose, requiring recurrent drainage procedures or an indwelling drainage catheter\n* Have a history of severe infections within 4 weeks prior to the start of study treatment\n* Hypertension (e.g., \\> 150\u002F100 mmHg) that cannot be controlled by medications despite optimal medical therapy\n* Other acute or chronic medical or psychiatric condition\n* Have a history of immunodeficiency, with a positive human immunodeficiency virus(HIV) test at screening\n* Known or suspected viral hepatitis with a positive test at screening\n* Had an adverse reaction to a previous antitumor treatment that has not recovered to CTCAE Grade ≤ 1\n* Have received chemotherapy within 4 weeks of the first dose of IMP; immunotherapy or biologic targeted antitumor treatments within 2 weeks before the first dose of IMP; small molecule inhibitors within 2 weeks before the first dose of IMP, or other investigational products within 4 weeks\n* Current radiation-related toxicity or radiation therapy within 2 weeks before the first dose of IMP\n* Administration of any of the following within 2 weeks before the first dose of IDE892 as a monotherapy: Strong inhibitors or inducers of cytochrome P450, Strong inhibitors of P-glycoprotein, Narrow therapeutic index and sensitive substrates of multidrug and toxin extrusion (MATE)1 and MATE2-K, Narrow therapeutic index and sensitive substrates of P-gp and breast cancer resistance protein\n* Administration of any of the following within 2 weeks before the first dose of IDE892: Strong inhibitors or inducers of CYP3A4\u002F5, Strong inhibitors of P-gp and\u002For BCRP, Narrow therapeutic index and sensitive substrates of MATE1 and MATE2-K, Narrow therapeutic index and sensitive substrates of P-gp and BCRP\n* Use of proton pump inhibitors (PPIs) within 7 days prior to the first dose of IMP or planned use during the study\n* Use of drugs with known risk for QT prolongation within 2 weeks prior to the first dose of IDE892\n* Previous treatment with a Amethionine adenosyltransferase 2A (MAT2A) inhibitor and\u002For Protein arginine N-methyltransferase (PRMT) inhibitor\n* Major surgery within 4 weeks before study entry\n* Prior irradiation to \\> 25% of the bone marrow\n* Known or suspected hypersensitivity to IDE892\n\nDisease-Specific Eligibility Criteria Eligibility Criteria for Participants with NSCLC (All Parts)\n\n* Must have histologically confirmed diagnosis of advanced or metastatic NSCLC that has progressed after prior treatment with platinum chemotherapy and a PD-1\u002FPD-L1 inhibitor (unless contraindicated or participant developed intolerance) in the metastatic setting\n* Treatment with no more than 3 prior lines in the setting of advanced or metastatic disease.\n* If considered standard of care and available, participants whose cancers have proven targetable oncogene alterations must have had disease progression on (unless contraindicated or participant developed intolerance) at least 1 prior line containing appropriate targeted therapy.\n\nEligibility Criteria for Participants with Urothelial Cancer (Bladder and Upper Urinary Tract), Mesothelioma (Pleural or Peritoneal), Pancreatic Adenocarcinoma or Biliary Tract Carcinomas (Intrahepatic and Extrahepatic Cholangiocarcinoma, and Gallbladder Cancer) (Parts 1 and 3)\n\n* Must have histologically confirmed diagnosis of advanced or metastatic UC, mesothelioma, gastroesophageal cancer or pancreatic and biliary tract tumors\n* Must have progressed following at least 1 prior line of therapy\n* Treatment with no more than 3 prior lines in the setting of advanced or metastatic disease","ALL","18 Years",{"count":19,"type":20},260,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a multicenter clinical study to evaluate the safety, efficacy, and Pharmacokinetics (PK) of IDE892 as monotherapy and in combination with other agents including IDE397 in participants with methylthioadenosine phosphorylase (MTAP)-deleted advanced solid tumors within indications of interest.",[26,27,28,29,30,31,32,33,34,35,36,37,38],"NSCLC Adenocarcinoma","Gastroesophageal Cancer (GC)","Gastric Adenocarcinoma","Adenocarcinoma of Esophagus","Squamous Cell Car. - Esophagus","Urothelial Carcinoma (UC)","Bladder Cancer","Mesothelioma","Pleural Mesothelioma","Peritoneal Mesothelioma","Non-Small Cell Lung Cancer NSCLC","Pancreatic Cancer","Biliary Tract Carcinoma",[40,41,42,43,44,45,46,47,48,49,50,51,52,53,54],"MTAP deletion","MTAP loss","MTAP-deficient tumors","homozygous MTAP loss","IDE892","IDE397","MAT2A inhibitor","PRMT5","advanced solid tumors","metastatic cancer","recurrent cancer","dose escalation","dose expansion","phase 1 clinical trial","ctDNA","RECRUITING","2026-06-19",{"date":58,"type":59},"2026-06-23","ACTUAL",{"date":61,"type":59},"2026-03-04",{"date":63,"type":20},"2028-04-30",{"name":65,"class":66},"IDEAYA Biosciences","INDUSTRY",14,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":21,"phases":77,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":5},"100625223","phase-1-a-phase-1-study-of-the-safety-and-tolerability-of-ctx-10726-100625223","NCT07419841","A Phase 1 Study of the Safety and Tolerability of CTX-10726","A Phase 1, Open-Label, Multiple-Ascending Dose Study of the Safety and Tolerability of CTX-10726 in Patients With Advanced Malignancies","Inclusion Criteria:\n\n1. Age 18 years or older.\n2. Patients must have a histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic disease that is relapsed\u002Frefractory to standard therapy or for which no effective standard therapy is available, including:\n\n2a: Renal Cell Carcinoma (RCC)\n\n* Histologically confirmed diagnosis of renal cell carcinoma (with clear cell component) with advanced or metastatic disease that is not amenable to cure by surgery or other means.\n* Patients who have progressed after a minimum of 2 doses of a programmed cell death 1 (PD-1)\u002F programmed cell death ligand 1 (PDL1) treatment.\n* Patients must have received at least one regimen including a tyrosine kinase inhibitor (TKI).\n* Patients who received immunomodulatory drugs (thymosin, interferon, interleukin, etc.) within 2 weeks before the first dose or received major surgical treatment within 3 weeks before the first dose are not eligible.\n\n  2b: Hepatocellular Carcinoma (HCC)\n* Patients who have progressed after a minimum of 2 doses of a PD-1\u002FPDL1 treatment.\n* Patient must have received one of the following regimens: ipilimumab+nivolumab, tremelimumab+durvalumab, atezolizumab+bevacizumab or lenvatinib+pembrolizumab.\n* Hepatic function: Child -Pugh A and Child-Pugh B7.\n* Receipt of local area treatment of the liver more than 4 weeks prior to the first dose is allowed.\n\n  2c. Gastroesophageal Cancer (GC)\n* Patients who have progressed after a minimum of 2 doses of a PD-1\u002FPDL1 treatment.\n* Patients must have received prior treatment with platinum-based chemotherapy.\n\n  2d: Endometrial Cancer (EC)\n* Patients must have received at least 1 cycle of platinum-based chemotherapy.\n* Patients with newly diagnosed advanced endometrial cancer that have persistent lesion(s) after standard treatment with surgery and chemotherapy ± radiotherapy.\n* Patients with MSI- high or deficient DNA mismatch repair (dMMR) tumors who have progressed after a minimum of 2 doses of a PD-1\u002FPDL1 treatment.\n\n  3\\. Patients must have measurable disease per RECIST 1.1. Tumor sites that are considered measurable must not have received prior radiation.\n\n  4\\. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n\n  5\\. Adequate organ function including:\n* Bone marrow function defined by absolute neutrophil (ANC) of ≥ 1.5×109\u002FL, platelet count of ≥ 100.0×109\u002FL, and hemoglobin of ≥ 9.0 g\u002FdL (with or without transfusion).\n* Hepatic function defined as serum total bilirubin ≤ 1.5 × ULN (\\\u003C3 x ULN in patients with Gilbert's syndrome), AST\u002FALT ≤ 2.5 × ULN (or ≤ 5 × ULN in patients with liver metastases).\n* Renal function defined as creatinine clearance ≥ 30 mL\u002Fmin by Cockcroft Gault equation.\n* Cardiac function with Left Ventricular Ejection Fraction (LVEF) ≥ 50%.\n\n  6\\. Female patients must be surgically sterile (or have a monogamous partner who is surgically sterile) or be at least 2 years postmenopausal or commits to use 2 acceptable forms of birth control (defined as the use of an intrauterine device, a barrier method with spermicide, condoms, any form of hormonal contraceptives) or abstinence for the duration of the study and for 4 months following the last dose of study treatment. Male patients must be sterile (biologically or surgically) or commit to the use of a reliable method of birth control (condoms with spermicide) for the duration of the study and for 4 months following the last dose of study treatment.\n\n  7\\. Female patients who are women of childbearing potential (WOCBP) must have a negative serum pregnancy test at Screening within 7 days of dosing with CTX-10726.\n\n  8\\. Prior anticancer therapy \\> 28 days (or 2 half-lives for proteins, whichever is shorter), radiotherapy \\> 7 days (concurrent localized palliative radiotherapy is allowed during CTX-10726 treatment with medical monitor approval), therapeutic surgical intervention \\> 21 days, blood transfusion \\> 14 days, or biopsy or minor surgery (excluding placement of vascular access devices) \\> 7 days prior to the first dose of CTX-10726.\n\n  9\\. Resolution of all prior anti-cancer therapy toxicities ≤ Grade 2 (excluding alopecia).\n\n  10\\. Capable of understanding and complying with protocol requirements\n\n  11\\. Signed and dated institutional review board (IRB) approved informed consent form (ICF) before any protocol-directed screening procedures are performed.\n\nExclusion Criteria:\n\n1. Developed clinically significant adverse reaction to prior PD-1 or PD-L1 therapy, including immune related adverse reactions (irAE), that led to discontinuation of treatment. A prior irAE may be considered not exclusionary only after consultation with the Medical Monitor if it resolved or stabilized to Grade 1 or baseline before informed consent, has been clinically stable for at least 3 months, and does not require ongoing systemic corticosteroids or other systemic immunosuppressive therapy other than protocol-permitted physiologic replacement. Participants are not eligible if the prior irAE was severe or life-threatening, involved a high-risk organ system with potentially dangerous recurrence, was recurrent or occurred after rechallenge, required second-line immunosuppressive therapy beyond corticosteroids, suggested broad immune susceptibility, or could confound safety evaluation in this first-in-human study.\n2. Prior organ transplantation.\n3. History of arterial or venous thrombosis or stroke or transient ischemic attack within 6 months prior to the first dose.\n4. History of other neoplasms within 3 years prior to screening, except basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or cervical cancer in situ that has undergone successful surgery.\n5. Symptomatic or uncontrolled central nervous system (CNS) and brain metastasis or active leptomeningeal disease. Patients with equivocal findings or with confirmed brain metastases are eligible for the study provided that they are asymptomatic and radiologically and neurologically stable without the need for corticosteroid treatment or seizure prophylaxis for \\>4 weeks before the first dose of study drug. Prior treatment with either surgery or radiation is permitted and all patients with a history of CNS or brain lesions require imaging during screening to confirm stability.\n6. A pleural, abdominal (eg, ascites) or pericardial effusion that is clinically symptomatic or requires repeated management (puncture or drainage, etc) within 14 days of dosing with CTX-10726.\n7. Imaging at screening that shows the tumor surrounds important blood vessels or had obvious necrosis and voids, and the investigators deems that it might cause bleeding risk.\n8. The presence of severe, unhealed or open wounds, active ulcers, or untreated fractures at the time of screening.\n9. A history of significant bleeding tendency or severe coagulopathy.\n10. Current therapeutic dose of anticoagulant or thrombolytic medication within 14 days of the first dose. Note: prophylactic use of low molecular heparin (ie, enoxaparin 40 mg\u002Fday) is allowed.\n11. Current or recent use of aspirin (\\> 325 mg\u002Fday) or other non-steroidal anti-inflammatory drugs (NSAIDs) within 14 days of first dose.\n12. Known uncontrolled diabetes mellitus despite optimized anti-diabetes medications.\n13. The presence of poorly controlled hypertension (systolic blood pressure \\[SBP\\]\u002Fdiastolic blood pressure \\[DBP\\]) \\>140\u002F90 mmHg (eg, patient with SBP\u002FDBP \\> 140\u002F90 mmHg despite ≥3 anti-hypertensive medications within 7 days of dosing with CTX-10726).\n14. Pregnant or lactating WOCBP.\n15. Patients with evidence of active hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection. Patients with positive HBsAg and\u002For detectable HBV DNA are eligible only if adequately controlled on antiviral therapy according to institutional standards and liver function eligibility criteria are also met. HCV patients showing sustained viral response or patients with immunity to HBV infection may enroll.\n\n    1. Hepatitis B subjects who meet the following criteria are also eligible for inclusion: HBV viral load must be \\\u003C 1000 copies \u002Fml (200 IU\u002Fml) prior to initial dosing, and subjects should receive anti-HBV therapy to avoid viral reactivation throughout the duration of study chemotherapy drug treatment. For subjects with anti-HBC (+), HBsAg (-), anti-HBS (-), and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring of viral reactivation is required.\n    2. HIV-infected subjects who meet the following criteria are eligible for inclusion: HIV-RNA levels below the lower limit of detection.\n16. Active HCV-infected subjects (HCV antibody positive and HCV-RNA levels above the lower limit of detection).\n17. Patients that received attenuated vaccination within 4 weeks prior to screening or planning to receive attenuated vaccination during the study period.\n18. Current or recent systemic therapy with immunosuppressive agents within 7 days before the start of CTX-10726 treatment. Topical, intranasal, intraocular, or inhaled corticosteroids and physiologic replacement (≤ 10 mg\u002Fday prednisone or equivalent) for patients with adrenal insufficiency are allowed.\n19. Active autoimmune disease or medical conditions requiring chronic steroid (i.e., \\> 10 mg\u002Fday prednisone or equivalent) or immunosuppressive therapy. Patients with a prior history of autoimmune disease may be eligible following discussion with the Medical Monitor.\n20. Active or prior documented idiopathic pulmonary fibrosis or idiopathic pneumonia; current acute lung disease, interstitial lung disease or pneumonia (except localized interstitial pneumonia due to radiotherapy induction), pulmonary fibrosis, severe respiratory distress, pulmonary insufficiency or continuous oxygenation.\n21. Other medical conditions in the opinion of the Investigator and\u002For Sponsor Medical Monitor may interfere with the conduct and\u002For interpretation of the current study, including:\n\n    1. Congestive heart failure (\\> New York Heart Association Class II), active coronary artery disease, unevaluated new onset angina within 3 months or unstable angina (angina symptoms at rest) or clinically significant cardiac arrhythmias.\n    2. QTc interval (using Fridericia correction calculation) \\> 480 msec.",{"count":76,"type":20},70,[23],"This is a Phase 1, open-label, first-in-human study of CTX-10726 monotherapy in patients with metastatic or locally advanced malignancies. The study will be conducted in 2 Cohorts: Cohort 1 Dose Escalation and Cohort 2 Dose Expansion.",[27,80,81,82],"Hepatocellular Carcinoma (HCC)","Endometrial Cancer","Renal Cell Carcinoma (RCC)","2026-06-04",{"date":85,"type":59},"2026-06-05",{"date":87,"type":59},"2026-05-28",{"date":89,"type":20},"2028-11-01",{"name":91,"class":66},"Compass Therapeutics",{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":21,"phases":102,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":122},"100637413","phase-2-befast-study-68gaga-fapi-total-body-petct-for-better-and-faster-imaging-in-cancer-100637413","NCT07629609","BEFAST Study, [68Ga]Ga-FAPI Total Body PET\u002FCT for Better and Faster Imaging in Cancer","[68Ga]Ga-FAPI Total Body PET\u002FCT for Improving Diagnostic Sensitivity and Preoperative Staging in Gastroesophageal Cancer and Pancreatic Cancer","BEFAST","Inclusion criteria for group A\n\n1. Male or female, over 18 years old\n2. Patients with suspected pancreatic cancer based on morphological findings on standard imaging\n3. CT or MRI or \\[18F\\]FDG PET\u002FCT evaluated on MDT with no initial sign of distant metastases\n4. Subjects must have been considered suitable for curative surgery at the time of the referral\n5. Subjects must be able to read and understand the patient information in Danish to give informed consent\n\nInclusion criteria for group B1\n\n1. Male or female over 18 years old\n2. Histological verified carcinoma from the lower esophagus, GEJ, or stomach\n3. Subjects must be considered operable and resectable at the time of referral for MDT\n4. Subjects must be able to read and understand the patient information in Danish to give informed consent\n\nInclusion criteria for group B2\n\n1. Male or female over 18 years old\n2. Histological verified SRCC or PCC from the lower esophagus, GEJ, or stomach\n3. Subjects with localized disease assigned to perioperative chemotherapy or subjects with metastatic disease assigned to palliative systemic treatment.\n4. Subjects must be able to read and understand the patient information in Danish to give informed consent\n\nExclusion Criteria:\n\n1. Pregnancy or lactation\n2. Weight more than the maximum limit of a PET\u002FCT-scanner bed (140 kg)\n3. History of allergic reaction due to compounds similar to the chemical composition of \\[68Ga\\]Ga-FAPI-46",{"count":101,"type":20},90,[103],"PHASE2","The goal of this clinical trial is to learn if \\[68Ga\\]Ga-FAPI-46 Total Body PET\u002FCT can diagnose patients suffering from gastroesophageal cancer and pancreatic cancer. The investigators hope that \\[68Ga\\]Ga-FAPI-46 Total Body PET\u002FCT can improve staging and treatment evaluation for these patient groups.\n\nThe main questions the trial aims to answer are:\n\n* Is \\[68Ga\\]Ga-FAPI-46 Total Body PET\u002FCT better at diagnosing metastatic disease in the abdomen compared other imaging modalities?\n* Can \\[68Ga\\]Ga-FAPI-46 Total Body PET\u002FCT produce accurate images in less than 30 min?\n\nResearchers will examine three different patient groups:\n\nGroup A) patients with pancreatic cancer, who are referred to surgery. Group B1) patients with gastroesophageal cancer, who are referred to diagnostic surgery (laparoscopy).\n\nGroup B2) a subgroup of gastroesophageal cancer patients, with a specific subtype cancer (signet ring cell carcinoma or poorly cohesive carcinoma), who are referred to oncological treatment.\n\nParticipants will undergo:\n\n* One \\[68Ga\\]Ga-FAPI Total Body PET\u002FCT before surgery (Group A), or before laparoscopy (group B1), or before oncological treatment (Group B2).\n* Participants in group B2 will also undergo a second \\[68Ga\\]Ga-FAPI-46 Total Body PET\u002FCT during treatment with chemotherapy.\n* All participants will fill out one questionnaire.\n* Researchers will follow the patients after the scans for 1 year.",[106,27],"Pancreatic Cancer, Adult",[108,109,110,111,112],"PET\u002FCT","FAPI","pancreatic cancer","gastroesophageal cancer","signet ring cell carcinoma","2026-06-01",{"date":85,"type":59},{"date":116,"type":59},"2024-01-16",{"date":118,"type":20},"2027-01",{"name":120,"class":121},"Barbara Malene Fischer","OTHER",1,{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":21,"phases":132,"briefSummary":133,"conditions":134,"keywords":146,"overallStatus":150,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":4},"100633678","phase-1-phase-12-study-of-bhb810-in-advanced-gastric-and-gej-adenocarcinoma-100633678","NCT07529808","Phase 1\u002F2 Study of BHB810 in Advanced Gastric and GEJ Adenocarcinoma","Phase 1\u002F2, Open-Label, Multicenter, Dose Escalation and Expansion Study of BHB810 in Participants With Advanced Gastric and Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n* Participant must be ≥ 18 years or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the ICF.\n* Histologically confirmed advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma that has progressed on, was nonresponsive to, or for which no standard or available curative therapy exists.\n\n  * Participants in Phase 1 Backfill Cohorts \\& Phase 2 must be CDH17-positive by central testing.\n  * Other gastrointestinal (GI) tumor types may be enrolled in Backfill Cohorts and Phase 2.\n* At least 1 measurable target lesion at baseline per RECIST 1.1 (Response Evaluation Criteria in Solid Tumors)\n* Provision of FFPE archival tumor tissue. Additional fresh biopsies at screening are required in Phase 1 Backfill Cohorts and Phase 2.\n* Adequate organ and marrow function as defined in the protocol\n\nExclusion Criteria:\n\n* Prior cancer treatment as follows, relative to the first planned dose of trial intervention:\n\n  * Chemotherapy or targeted therapy withing 4 weeks or 5-halflives (whichever is shorter)\n  * Monoclonal antibody-based therapy (including ADCs) within 4 weeks\n  * Immune checkpoint inhibitors within 4 weeks\n  * Wide-field radiation therapy (\\>30% marrow-bearing bones) within 4 weeks or \\\u003C 2 weeks of focal palliative radiation to nontarget lesions\n* Prior treatment with a CDH17-directed therapy or an ADC with an auristatin (MMAE or MMAF)\n* Known hypersensitivity or allergic reaction to BHB810 or it's excipients\n* Left ventricular ejection fraction \\\u003C50% or history of congestive heart failure Class III\u002FIV\n* QTc interval \\> 470 msec, history of risk factors for Torsade de Pointes, or taking a medication known to prolong QT\u002FQTc\n* Pregnant or breastfeeding females, or if you or your partner are planning to become pregnant\n* Known or suspected brain metastases, leptomeningeal disease, or spinal cord compression. Participants with stable, treated brain metastases may be enrolled.\n* Current treatment with a strong CYP3A4 inhibitor or inducer, Pgp inhibitor, or CYP3A4 sensitive substrate within 2 weeks of first dose of trial intervention\n* Any condition that may compromise participant safety, compliance, or interfere with the evaluation of the study drug.",{"count":131,"type":20},164,[23,103],"This study is looking at how safe BHB810 is in adults with gastric and gastroesophageal adenocarcinoma (GEJ). The purpose of this study is also to look at: how well the study drug works, how the study drug moves into, through, and out of the body, and how your body reacts to the study drug. Participants will get an IV infusion of BHB810 every 2 weeks while on study treatment.",[135,28,136,137,27,138,139,140,141,142,143,37,144,145],"Gastric Cancer","Gastric (Stomach) Cancer","Gastroesophageal Adenocarcinoma","Gastroesophageal Junction (GEJ) Adenocarcinoma","Gastroesophageal Junction (GEJ) Cancer","Gastrointestinal Cancer Metastatic","Gastrointestinal Adenocarcinoma","Gastrointestinal Cancers","Colorectal (Colon or Rectal) Cancer","CDH17-positive Advanced Solid Tumors","Advanced Gastric Cancer",[147,148,149],"Antibody Drug Conjugate (ADC)","Monomethyl Auristatin E (MMAE)","CDH17 protein","NOT_YET_RECRUITING","2026-05-05",{"date":153,"type":59},"2026-05-08",{"date":155,"type":20},"2026-06",{"date":157,"type":20},"2028-12",{"name":159,"class":66},"BigHat Biosciences, Inc.",{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":167,"targetDuration":169,"studyType":170,"phases":4,"briefSummary":171,"conditions":172,"keywords":181,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":122},"100568904","cognitive-impact-associated-with-surgery-for-gastric-or-esophageal-cancer-100568904","NCT06687291","Cognitive Impact Associated With Surgery For Gastric Or Esophageal Cancer","CASE","Inclusion Criteria:\n\n* Patients diagnosed with esophageal or gastric cancer, treated with (or without) chemotherapy and surgery.\n* Age ≥18 at the time for inclusion.\n* Participate on a voluntary basis and can (for any reason) end its participation during the study.\n* Capable of giving informed consent.\n\nExclusion Criteria:\n\n* Patients with preoperative cognitive dysfunction such as dementia.\n* Patients who are inoperable due to metastases.\n* Patients unable to communicate due to severely impaired hearing and\u002For - seeing.\n* Patients with ongoing drug and\u002For alcohol abuse.\n* Patients who cannot give informed consent.",{"count":168,"type":20},130,"6 Months","OBSERVATIONAL","The primary objective of this observational study is to investigate the incidence of Post Operative Delirium (POD) after gastroesophageal cancer surgery. Secondary objectives are to investigate the relationship between POD, preoperative depression, frailty, quality of life, malnutrition and sarcopenia.\n\nParticipants identified with POD will be asked (at the routine follow-up meeting after surgery) to participate in an qualitative interview, in order to understand the participant's experience of postoperative delirium.\n\nThe main objective aims to answer:\n\nWhat is the incidence of POD after gastroesophageal cancer surgery.",[27,173,174,175,176,177,178,179,180],"Postoperative Delirium (POD)","Quality of Life (QOL)","Frailty","Malnutrition","Sarcopenia","Chemobrain","Chemotherapy","Depression",[182,111,175,183,184,176,177,178,179],"postoperative delirium","Quality of life","Preoperative depression","2025-06-28",{"date":187,"type":59},"2025-07-02",{"date":189,"type":59},"2025-02-13",{"date":191,"type":20},"2027-11-11",{"name":193,"class":121},"Karolinska Institutet"]